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The aim of this study was to develop and characterize in situ thermosensitive gels for the vaginal administration of sildenafil as a potential treatment of the endometrial thinning that occurs as a result of the use of clomiphene citrate in induction of ovulation in women with World Health Organization type II EU gonadotrophic anovulation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| preparation F12 sildenafil in-situ gel group | Experimental | women received clomiphene citrate 150 mg/d in three divided doses 50 mg each starting from day 2 of menstruation for 5 days + preparation F12 sildenafil gel vaginally from day 5 to day 12 of menstrual cycle twice daily by a specific applicator (25 mg) per dose |
|
| preparation F2 sildenafil in-situ gel group | Active Comparator | women received clomiphene citrate 150 mg/d in three divided doses 50 mg each starting from day 2 of menstruation for 5 days + preparation F2 sildenafil gel vaginally from day 5 to day 12 of menstrual cycle twice daily by a specific applicator (25 mg) per dose |
|
| placebo gel group | Placebo Comparator | women received clomiphene citrate 150 mg/d in three divided doses 50 mg each starting from day 2 of menstruation for 5 days + placebo gel vaginally from day 5 to day 12 of menstrual cycle twice daily by a specific applicator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| preparation F12 sildenafil in situ gel | Drug | in situ vaginal gel |
|
| Measure | Description | Time Frame |
|---|---|---|
| The change of Doppler resistance index after the treatment | 10 days |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27783532 | Derived | Soliman GM, Fetih G, Abbas AM. Thermosensitive bioadhesive gels for the vaginal delivery of sildenafil citrate: in vitro characterization and clinical evaluation in women using clomiphene citrate for induction of ovulation. Drug Dev Ind Pharm. 2017 Mar;43(3):399-408. doi: 10.1080/03639045.2016.1254239. Epub 2016 Nov 14. |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| preparation F2 sildenafil in situ gel | Drug | in situ vaginal gel |
|
| placebo gel | Drug | vaginal gel |
|